The following data is part of a premarket notification filed by Koi, Inc. with the FDA for Koi Lacremal Hook & Dilator.
| Device ID | K812097 |
| 510k Number | K812097 |
| Device Name: | KOI LACREMAL HOOK & DILATOR |
| Classification | Dilator, Lachrymal |
| Applicant | KOI, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HNW |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-24 |
| Decision Date | 1981-08-18 |